Evgen Pharma plc (LON:EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, has today announced that the first patient has been dosed in the Company’s Phase II clinical trial of SFX-01 in breast cancer.
The STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial is investigating SFX-01 in combination with different hormone-based therapies in 60 metastatic breast cancer patients whose cancer cells are estrogen-receptor positive (ER+). The primary objectives of the STEM trial are to evaluate safety and efficacy (via tumour imaging) in patients starting to become resistant to mainstream hormone therapy. Patients will be enrolled into one of three study arms (SFX-01 in combination with either aromatase inhibitors, tamoxifen or fulvestrant) based on their current therapy.
The STEM trial is being led by Chief Investigator Dr Sacha Howell at Manchester’s Christie NHS Foundation Trust, Europe’s largest single-site cancer centre, and will include approximately 15 sites in 5 countries.
The first patient was dosed on 16 January 2017 at the Cliniques universitaires Saint-Luc, the largest hospital in Brussels, Belgium.
One proposed mechanism for the generation of resistance to hormone therapy is via the proliferation of hormone-independent breast cancer stem cells. Such cells are known to proliferate during treatment with hormonal agents and it is thought they could have the effect of repopulating the tumour to render it hormone-independent. Earlier work by the Company with xenograft models suggests that SFX-01 has the effect of reducing the number of hormone-independent cancer stem cells.
SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.
Dr Stephen Franklin, CEO of Evgen Pharma Plc, commented: “The first patient being dosed in this Phase II trial of SFX-01 in breast cancer is another major milestone for Evgen Pharma. We would like to thank all of the investigators and sites participating in this exciting trial, which is seeking to demonstrate that SFX-01 is safe, well tolerated and can positively impact the resistance to hormone-based therapy in metastatic breast cancer patients.”
The company also announced today the appointment of Richard Moulson, an experienced healthcare executive, as the Company’s Chief Financial Officer (“CFO”).
Richard joins Evgen Pharma today as CFO designate for a handover period to 28 February 2017, on which date John Bradshaw, the current CFO, will leave the Company to focus on his work with a new healthcare investment vehicle.
Richard will join the Company’s Board and become CFO on 1 March 2017.
Richard graduated in zoology at Exeter University before qualifying as an accountant at Coopers & Lybrand. He worked in corporate finance at Deutsche Morgan Grenfell for 10 years before working in financial and company secretarial roles at a number of UK biotechnology and technology companies. Since 2012, Richard has had a portfolio of interests, including recently as CFO of Cogent Breeding Limited and previously as Interim CFO of ReNeuron Group plc and Interim CFO of Enigma Diagnostics Limited.
The Company also announces that David Howat, who holds the non-Board position of Chief Development Officer, will leave Evgen Pharma at the end of March 2017. David led the preclinical and early-stage clinical development of the Company’s lead product (SFX-01) through to the Phase II trials. The Phase II trials will continue to be managed by Dave Chadwick, the Company’s Senior Clinical Study Manager, who, on 1 March 2017, assumes the role of Head of Clinical Operations, a non-Board position.
Dr Stephen Franklin, CEO, commented: “On behalf of the Board, I would like to express our sincere thanks to John Bradshaw for his valuable contribution to the development of Evgen Pharma, including his important role in the Company’s IPO. We wish him well for the future”.
“I would like to welcome Richard Moulson to Evgen Pharma. Richard is an experienced CFO with a track record in life sciences and we all look forward to his input to the Company and to the Board”.
“Finally, I would like to thank David Howat for being a tremendous asset to Evgen Pharma during our formative years and for helping take our lead product through to the current patient trials, which are managed by our clinical team. David leaves us to join an earlier-stage company and the Board extends its thanks and wishes him every success in his new role.”